Brand Name | UCENTUM |
Type of Device | ROD, 6MM, STRAIGHT, LENGTH 45MM, |
Manufacturer (Section D) |
ULRICH GMBH AND CO. KG |
buchbrunnenweg 12 |
ulm, baden-wurttemberg 89081 |
GM 89081 |
|
MDR Report Key | 18822786 |
MDR Text Key | 336734520 |
Report Number | 3005823819-2024-00003 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/01/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | CS 3807-045 |
Device Catalogue Number | CS 3807-045 |
Device Lot Number | U038012 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/27/2024 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/01/2024 |
Device Age | 1 YR |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/01/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 83 YR |
Patient Sex | Male |
Patient Weight | 120 KG |
|
|